BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 CORE

    MDR report key: 1078038 · Received July 16, 2008

    Report

    Report Number
    1823260-2008-05465
    Event Type
    Malfunction
    Date Received
    July 16, 2008
    Date of Event
    July 1, 2008
    Report Date
    July 16, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    USER REC'D DISCREPANT POTASSIUM AND SODIUM RESULTS. INITIAL AND FIRST REPEAT ARE IN MMOL/L. SECOND REPEAT IS IN MMOL/L AND WAS PERFORMED ON OTHER METHODOLOGY. SAMPLE 1: POTASSIUM RESULTS 4.1, 4.4, 5.3; SODIUM RESULTS 126, 140, 134. SAMPLE 2: POTASSIUM RESULTS 4.7, 5.2, 5.6; SODIUM RESULTS 113, 131, 127. SAMPLE 3: SODIUM RESULTS 129, 138, 141. SAMPLE 4: SODIUM RESULTS 130, 136, 139. SAMPLE 5: SODIUM RESULTS 134, 150, 145. SAMPLE 6: 130, 146, 142. INITIAL RESULTS WERE REPORTED. NO ADVERSE EVENTS WERE REPORTED. FIELD SERVICE REPRESENTATIVE DETERMINED ROOT CAUSE TO BE A BAD SODIUM ELECTRODE CAUSING THE POTASSIUM ELECTRODE TO READ LOW AND REPLACED THE SODIUM ELECTRODE. PERFORMANCE TESTS WERE PERFORMED WHICH WERE WITHIN SPECIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS 6000 CORE CLINICAL CHEMISTRY ANALYZER - JJE JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK